Efficacy of Intraosseous Local Anesthesia for Restorative Procedures in Molar Incisor Hypomineralization-Affected Teeth in Children.
Uma B Dixit, Amil V Joshi
https://pubmed.ncbi.nlm.nih.gov/30294157/Actively Recruiting
Led by Ankara Yildirim Beyazıt University · Updated on 2026-01-20
30
Participants Needed
1
Research Sites
3 weeks
Total Duration
Researchers are evaluating the clinical effectiveness of two anesthesia techniquescomputer-assisted intraosseous and infiltration anesthesiain children aged 6 to 12 years with Molar-Incisor Hypomineralization MIH affecting their permanent first molars. The study compares these methods during restorative dental treatments by measuring pain levels, behavioral responses, pulse rates, and salivary chromogranin A levels, aiming to find a minimally invasive and effective anesthesia approach for this sensitive condition. The study involves 30 children who receive both anesthesia methods in separate sessions spaced at least one week apart. Each session includes anesthesia administration using the SleeperOne 5 device on either the right or left upper first permanent molar, followed by removal of carious tissue and restorative treatment. The order of anesthesia types is randomized, and the opposite side molar receives the alternative technique in a third session. Participants will have their pain assessed using the Visual Analogue Scale VAS, behavior observed with the FLACC scale, and pulse rate monitored throughout the procedures. Saliva samples are collected before anesthesia, after anesthesia application, and post-treatment for biochemical analysis. Behavioral responses are video recorded for unbiased evaluation. The study will measure the need for additional anesthesia and overall anesthesia efficacy, with all data collected over multiple visits to inform best clinical practices.
CONDITIONS
Intraosseous vs Infiltration Anesthesia in Molar-Incisor Hypomineralization (MIH) Children
G
Gülsevim Oda, Assistant professor, pHD
E
Esra Koçak
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Ankara Yildirim Beyazıt University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 sessions with at least 1 week between each session
Participants attend three treatment sessions spaced at least one week apart. In the first session, medical and dental histories are collected and teeth are examined without any invasive procedures. The second and third sessions each involve administration of a different anesthesia technique to a specified molar, followed by restorative dental treatment. During treatment, saliva samples and pulse rate measurements are collected, pain levels are assessed, behavioral responses are recorded, and anesthesia efficacy is evaluated.
3 treatment visits (in-person)
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Uma B Dixit, Amil V Joshi
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https://pubmed.ncbi.nlm.nih.gov/40445534/S Berrendero, O Hriptulova, M P Salido...
https://pubmed.ncbi.nlm.nih.gov/32862249/Ankara Yildirim Beyazıt University
Lead Sponsor